chronic hepatitis B
Conditions
Interventions
Participants will be assigned to CVP-NASVAC group or placebo group. CVP-NASVAC or placebo will be given total 10 doses every 2 weeks.
Sponsors
Hiasa Yoichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HBV carriers who fulfill the inclusion criteria below (1) 20-85 years old (2) Positive for HBsAg or HBV-DNA (3) Not under nucleos(t)ide analogue or interferon treatment (4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS: 0-2) (5) No evidence of organ dysfunction Liver: Child-Pugh Score less than 9 Kidney: eGFR more than 30 Heart: No severe heart failure by interview Lung: SpO2 above 90% in room air
Exclusion criteria
Exclusion criteria: (1) Allergic history of past vaccination (2) Pregnant, unwilling to practice contraception during the study or lactating female (3) Severe complication (malignant hypertension, severe congestive heart failure, severe liver failure, poorly controlled diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonia) (4) Bearing malignant carcinoma including HCC (5) Severe mental disability (6) Positive for HCV-RNA (7) Taking immunosuppressive drugs, steroid, interferon prior 90 days (8) Taking nucleos(t)ide analogues (9) Inappropriate to participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| amount of HBsAg reduction HBsAg loss (below 0.005 IU/mL by CLEIA) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| amount of HBV-DNA reduction amount of HBcrAg reduction HBeAg seroconversion rate anti-HBs induction (more than 1.0 mIU/mL by CLEIA) rate HBcAg specific CTL induction | — |
Contacts
Public ContactOsamu Yoshida
Ehime University
Outcome results
None listed